otential differences among racial and ethnic groups in the metabolism, effectiveness, and side-effect profiles of novel investigational medicinal products (IMPs) underscore the need to enroll participants from diverse populations into clinical trials. If medical care is not tailored to all who need it, certain categories of patients will be left behind. Regulators have realized this, and sponsors must be prepared to comply with new regulatory expectations. This article addresses the proactive steps sponsors can take to prepare for the submission of clinical trial diversity plans to regulators, and more specifically the US FDA.

egulators’ expectations of patient involvement in drug development are growing, while new tools are helping to remove practical barriers to working with patients. A multistakeholder group is co-creating a repository of resources that can accelerate progress ahead of the DIA Europe 2023 DIAmond Session on 24 March 2023. The road ahead is clear; only the speed of progress is in doubt.

n 2010, the Deloitte Life Sciences and Healthcare Industry Group collaborated with the Economist Intelligence Unit on a white paper addressing the future of the life sciences industries after the 2008 and 2009 global recession. With feedback from senior executives, C-level executives, and board members, this paper highlighted the growing importance of emerging markets. China, India, Brazil, Russia, Mexico, and Turkey were identified as these emerging markets, but not a single African country.

oth experienced and aspiring research professionals with an interest in participating in more global drug development and clinical research activities are keen to see an increase in the contribution of African countries to global research programs and in the increased arsenal of interventions that could potentially increase treatment options for their patients.

he life sciences industry must engage with the many key opinion leaders and subject matter experts across the African continent who offer deep technical and scientific knowledge about their patient populations, standards of care, health systems, challenges, strengths, and cultural particularities and priorities. The inclusion of more African countries in global clinical trials brings both concerns and hopes for researchers across the continent.

ew, updated Good Publication Practice Guidelines for Company-Sponsored Biomedical Research (GPP) published by the GPP Steering Committee in September 2022 aimed at supporting publication of company-sponsored biomedical research and includes important new topics such as working effectively with patients.

ince initiating the process of pre-admission to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2021, the National Medical Products Administration (NMPA) has been actively taking part in PIC/S-related activities in preparation to become a PIC/S participating authority. To foster better understanding of and promote GMP regulation harmonization and inspection conformance across countries, a PIC/S workshop was held during the DIA China 2022 Annual Meeting. As an exchange of mutual experience in support of China to join PIC/S, these discussions (summarized below) covered the latest regulatory considerations and requirements to ensure product quality and patient safety from various perspectives.

ffective January 1, 2023, in accordance with the requirements of the NMPA Announcement (No. 110, 2022) on the Implementation of Electronic Submission for Drug Registration (Chinese only) released on November 30, 2022, all regulatory submissions for clinical trial applications, new drug applications, and all supplementary dossiers thereto must be submitted in electronic format. Applicants may no longer submit any paper documentation.

o many casual observers, pharmacovigilance (PV) and medical writing (MW) can appear as two disconnected pieces in the drug development lifecycle. In many organizations, PV and MW are two different functions, working in two different silos. Different terminology between these two fields doesn’t do much to correct this perception.

he Act on Anonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (commonly known as the “Next-Generation Medical Infrastructure Law” [hereafter, NGMIL]) is a law enacted in May 2017 in Japan. Its purpose is to achieve both protection of personal information and promotion of the use of medical information/data, aiming to develop economic society and improve public health. It came into force in May 2018. But progress has been slow, and more cooperation is needed among different stakeholders to implement it in full. The NGMIL Supplementary Rules state: “At the time when 5 years have passed after the enforcement of the Act, the implementation status shall be examined, and measures shall be taken as necessary.” A working group for this purpose has already been established and started, and 2023 is the opportune time to discuss NGMIL.

he use of technology in clinical trials has increased dramatically. Although technology is now used at all levels of the process, from molecule discovery, trial logistics, and participant selection, clinical trial endpoint measurement is also gaining traction, with substantial growth in recent years. In fact, 378 unique digital endpoints are currently being used by 104 sponsors across a wide range of therapeutic areas. But some challenges still stand in the way of fully describing digital endpoints and measures in drug labeling.